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February 4, 2004

Regulation of Dietary Supplements

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2004;291(5):560. doi:10.1001/jama.291.5.560-a

To the Editor: We have several concerns about the Editorial by Drs DeAngelis and Fontanarosa1 regarding the regulation of dietary supplements.

There is no substantiation of the claim by DeAngelis and Fontanarosa that postmarketing regulation by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) presents a "real danger" to the public. Their assertion that the "onus is on FDA to demonstrate" a lack of safety is only partially true. "New dietary ingredients" are marketed following approval of safety files by the FDA. We believe that existing food ingredients and supplements are safe based on years of uneventful human ingestion. Furthermore, the Dietary Supplement Health and Education Act (DSHEA) grants the right to take action if a supplement poses "an imminent hazard to public health" or "presents a significant or unreasonable risk of illness or injury."

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